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    QA Associate

    CorkContractCompetitive
    Back to job search
    7 hours ago
    JN -072025-1984458
    New

    QA Associate

    Cork Contract Competitive

    QA Associate

    About the job

    We're looking to hire a QA professional to join our clients team. Your role will be to support an environment of continuous improvement by identifying and implementing efficiencies and quality improvements. You will be working within a team to ensure the quality of products will meet company standards.

    Key Responsibilities

    • Supporting and leading daily on cross functional teams to aid with compliance issues and achieve project milestones.
    • Investigations and risk assessments in regards to deviations, complaints and changes are addressed and dealt with in a timely manner.
    • Providing QA oversight for validation in Deviations, CAPAs/ SOPS, Change Controls as well as similar documentation in relation to GMP and site regulations.
    • Providing QA knowledge into Tech transfers and regulatory approvals as well as quality / validation operations at the facility.
    • Assist in the development of training curricula and records for the QA Operations Group, providing SME training on Quality Assurance SOPs as required.
    • Creating and maintaining SOPs and QA documentation in line with site requirements.
    • Participate in and support risk management activities with relative insight and good practice.
    • Participating in audits and cross-functional teams to ensure the best performance.
    • Driving continuous improvement and working within a team to build strong relationships with management as well as colleagues.
    • Escalating compliance risks as needed and delivering training while supporting enhancements to our Quality System

    Skills, Attributes & Experience

    • Bachelor's or Masters degree in Engineering, Science or related discipline.
    • Minimum of 4+ years experience working in QA in a cGMP manufacturing environment and a deep understanding of regulatory requirements.
    • Strong communication skills, both written and verbal
    • Proactive, logical thinker with the ability to perform well under pressure.
    • Team player who can also work independently
    • High attention to detail in reviewing GMP documentation
    • Experience with quality systems (e.g., Veeva, SAP, PAS-X)
    • Knowledge of FDA, HPRA, EMEA, and other regulatory requirements
    • Experience supporting regulatory inspections and agency interactions

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